Drive Mechanism for a Drug Delivery Device and Drug Delivery Device

ABSTRACT

The drive mechanism comprises a lead screw ( 5 ) and a lead screw nut, which are aligned with an axis ( 4 ). The lead screw has screw threads ( 6, 16 ) having the same pitch and being intertwined.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a U.S. National Phase application pursuant to35 U.S.C. §371 of International Application No. PCT/EP2011/067416 filedOct. 5, 2011, which claims priority to European Patent Application No.10186732.3 filed Oct. 6, 2010. The entire disclosure contents of theseapplications are herewith incorporated by reference into the presentapplication.

FIELD OF INVENTION

The present invention relates to a drive mechanism for a drug deliverydevice, especially for a device that is designed for the delivery offixed doses.

BACKGROUND

Portable drug delivery devices are used for the administration of a drugthat is suitable for self-administration by a patient. A drug deliverydevice is especially useful in the shape of a pen, which can be handledeasily and kept everywhere available. A drug is delivered by means of adrive mechanism, which may also serve to set the dose that is to bedelivered. A type of drug delivery device is constructed to berefillable and thus reusable many times.

DE 102 37 258 B4 describes a drug delivery device in the shape of aninjection pen, which has a drive mechanism with elements that arerotated with respect to one another around a common axis.

It is an object of the present invention to disclose a new drivemechanism for a drug delivery device and a drug delivery devicecomprising a new drive mechanism.

This object is achieved by a drive mechanism according to claim 1 and adrug delivery device according to claim 9, respectively. Further objectsare achieved by embodiments according to the dependent claims.

SUMMARY

The drive mechanism for a drug delivery device comprises a lead screwand a lead screw nut, which are aligned with an axis defining an axialdirection and an opposite axial direction. The lead screw has a screwthread and at least one further screw thread, the screw thread and thefurther screw thread having the same pitch and being intertwined. Thusthe lead screw may have intertwined co-axial helical thread featureswith separate entries. A drive feature of the lead screw nut engages thescrew thread and the further screw thread and allows a helical movementof the lead screw with respect to the lead screw nut at least in theaxial direction.

The drive mechanism and the drug delivery device provided with the drivemechanism comprise a lead screw with a screw thread, which is preferablyformed to facilitate the operation of the mechanism. One feature of thescrew thread, which is a helix surrounding a central axis, may be anon-zero opening angle in the radial directions with respect to thecentral axis. Thereby a buttressed thread form is achieved, whichfacilitates a centring of the lead screw with respect to furthercomponents of the mechanism.

In an embodiment of the drive mechanism the drive feature of the leadscrew nut engages the screw threads of the lead screw between surfacesof the screw threads. The surfaces of the screw threads form a non-zeroangle in the radial directions diverging from the axis.

A further embodiment of the drive mechanism may further comprise a drivemember, which is rotationally locked with the lead screw nut. The leadscrew is coupled with the drive member, so that the coupling generates ahelical movement of the lead screw with respect to the drive member whenthe drive member is moved in the axial direction with respect to thelead screw. The coupling is overridden to prevent a helical movement ofthe lead screw with respect to the drive member when the drive member ismoved in the opposite axial direction with respect to the lead screw.

A further embodiment of the drive mechanism may further comprise aflexible guide feature of the lead screw and a screw thread of the drivemember. The flexible guide feature of the lead screw and the screwthread of the drive member provide the coupling of the lead screw withthe drive member.

In a further embodiment of the drive mechanism the screw thread of thedrive member has two separate co-axial helical features.

A further embodiment of the drive mechanism comprises stop features ofthe lead screw. The stop features are provided to inhibit the helicalmovement of the lead screw when the drive member is moved in theopposite axial direction with respect to the lead screw.

In a further embodiment of the drive mechanism the drive feature of thelead screw nut comprises at least two separate parts protruding from aninner sidewall of the lead screw nut.

In a further embodiment of the drive mechanism the drive feature of thelead screw nut is tapered towards the screw thread of the lead screw.

In another aspect of the invention, a drug delivery device is providedwith the drive mechanism. The drug delivery device comprises a body,which has a distal end and a proximal end, which are spaced apart in thedirection of the axis of the drive mechanism.

The body can be any housing or any component that forms part of ahousing, for example. The body can also be some kind of an insertconnected with an exterior housing. The body may be designed to enablethe safe, correct, and/or easy handling of the device and/or to protectit from harmful liquids, dust or dirt. The body can be unitary or amultipart component of tubular or non-tubular shape. The body may housea cartridge, from which doses of a drug can be dispensed. The body canespecially have the shape of an injection pen.

The term “distal end” refers to a part of the body or housing which isintended to be arranged at a portion of the drug delivery device fromwhich a drug is dispensed. The term “proximal end” refers to a part ofthe body or housing which is remote from the distal end. The term“distal direction” refers to a movement in the same direction as amovement from the proximal end towards the distal end, not specifying apoint of departure nor an end point, so that the movement may go beyondthe distal end. The term “proximal direction” refers to a movement inthe direction opposite to the distal direction.

The term “lead screw” encompasses any element, whether unitary or ofmultipart construction, that is provided to transfer a movement to apiston, thus working as a piston rod, especially for the purpose ofdispensing a drug. The lead screw may be flexible or not.

The drive mechanism can be used to expel a drug from a receptacle orcartridge inserted in the body of a drug delivery device. The drugdelivery device can be a disposable or re-usable device designed todispense a dose of a drug, especially a liquid, which may be insulin, agrowth hormone, a heparin, or an analogue and/or a derivative thereof,for example. The drug may be administered by a needle, or the device maybe needle-free. The device may be further designed to monitorphysiological properties like blood glucose levels, for example. Eachtime the lead screw is shifted in the distal direction with respect tothe body, a certain amount of the drug is expelled from the drugdelivery device.

The term “drug”, as used herein, preferably means a pharmaceuticalformulation containing at least one pharmaceutically active compound,

wherein in one embodiment the pharmaceutically active compound has amolecular weight up to 1500 Da and/or is a peptide, a proteine, apolysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody, ahormone or an oligonucleotide, or a mixture of the above-mentionedpharmaceutically active compound,

wherein in a further embodiment the pharmaceutically active compound isuseful for the treatment and/or prophylaxis of diabetes mellitus orcomplications associated with diabetes mellitus such as diabeticretinopathy, thromboembolism disorders such as deep vein or pulmonarythromboembolism, acute coronary syndrome (ACS), angina, myocardialinfarction, cancer, macular degeneration, inflammation, hay fever,atherosclerosis and/or rheumatoid arthritis,

wherein in a further embodiment the pharmaceutically active compoundcomprises at least one peptide for the treatment and/or prophylaxis ofdiabetes mellitus or complications associated with diabetes mellitussuch as diabetic retinopathy,

wherein in a further embodiment the pharmaceutically active compoundcomprises at least one human insulin or a human insulin analogue orderivative, glucagon-like peptide (GLP-1) or an analogue or derivativethereof, or exedin-3 or exedin-4 or an analogue or derivative ofexedin-3 or exedin-4.

Insulin analogues are for example Gly(A21), Arg(B31), Arg(B32) humaninsulin; Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) humaninsulin; Asp(B28) human insulin; human insulin, wherein proline inposition B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein inposition B29 Lys may be replaced by Pro; Ala(B26) human insulin;Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) humaninsulin.

Insulin derivates are for example B29-N-myristoyl-des(B30) humaninsulin; B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl humaninsulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin;B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30human insulin; B29-N-(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;B29-N-(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin andB29-N-(ω-carboxyheptadecanoyl) human insulin.

Exendin-4 for example means Exendin-4(1-39), a peptide of the sequenceH-His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following listof compounds:

H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2, des Pro36 [Asp28]Exendin-4(1-39), des Pro36 [IsoAsp28] Exendin-4(1-39),des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); ordes Pro36 [Asp28] Exendin-4(1-39), des Pro36 [IsoAsp28] Exendin-4(1-39),des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),

wherein the group -Lys6-NH2 may be bound to the C-terminus of theExendin-4 derivative;

or an Exendin-4 derivative of the sequence

H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2,des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,H-des Asp28 Pro36, Pro37, Pro38[Trp(O2)25] Exendin-4(1-39)-NH2,H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2,H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Met(O)14, Asp28]Exendin-4(1-39)-Lys6-NH2,des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-NH2, des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-(Lys)6-NH2,H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-(Lys)6-NH2,H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-(Lys)6-NH2,H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25]Exendin-4(1-39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]Exendin-4(1-39)-NH2,H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-NH2,des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2,H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(S1-39)-(Lys)6-NH2,H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]Exendin-4(1-39)-(Lys)6-NH2;

or a pharmaceutically acceptable salt or solvate of any one of theafore-mentioned Exedin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones orregulatory active peptides and their antagonists as listed in RoteListe, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin,Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin),Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin,Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example a glucosaminoglycane, a hyaluronic acid,a heparin, a low molecular weight heparin or an ultra low molecularweight heparin or a derivative thereof, or a sulphated, e.g. apoly-sulphated form of the above-mentioned polysaccharides, and/or apharmaceutically acceptable salt thereof. An example of apharmaceutically acceptable salt of a poly-sulphated low molecularweight heparin is enoxaparin sodium.

Pharmaceutically acceptable salts are for example acid addition saltsand basic salts. Acid addition salts are e.g. HCl or HBr salts. Basicsalts are e.g. salts having a cation selected from alkali or alkaline,e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1)(R2)(R3)(R4), whereinR1 to R4 independently of each other mean: hydrogen, an optionallysubstituted C1-C6-alkyl group, an optionally substituted C2-C6-alkenylgroup, an optionally substituted C6-C10-aryl group, or an optionallysubstituted C6-C10-heteroaryl group. Further examples ofpharmaceutically acceptable salts are described in “Remington'sPharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), MarkPublishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia ofPharmaceutical Technology.

Pharmaceutically acceptable solvates are for example hydrates.

BRIEF DESCRIPTION OF THE DRAWINGS

Exemplary embodiments are described herein with reference to thedrawings, in which:

In the following, a more detailed description of examples andembodiments of the drive mechanism is given in conjunction with theappended figures.

FIG. 1 shows a cross-section of an injection pen comprising anembodiment of the drive mechanism.

FIG. 2 shows a perspective view of the lead screw.

FIG. 3 shows a cross-section of the lead screw nut.

FIG. 4 shows an enlarged view of the distal end of the lead screw.

DETAILED DESCRIPTION

FIG. 1 shows a cut-away view of an injection pen comprising the drivemechanism. The drive mechanism is arranged in a body 1 having a distalend 2 and a proximal end 3. A lead screw 5 is arranged along an axis 4of the device. A screw thread 6 of the lead screw 5 is coupled to adrive feature of a lead screw nut 7 engaging the screw thread 6, inorder to guide a helical movement of the lead screw 5 with respect tothe lead screw nut 7. In further embodiments, the screw thread and thedrive feature can be reversed such that the lead screw is provided withdiscrete drive features and the lead screw nut is provided with ahelical screw thread. The lead screw nut 7 is rotationally locked to thebody 1.

The embodiment shown in FIG. 1 comprises a drive member 8, which can beoperated by the user by means of a button 9, which is arranged at theproximal end 3 and juts out of the body 1. The drive member 8 is coupledor engaged with the lead screw 5. This is achieved, in this embodiment,by means of a screw thread 18 of the drive member 8 and a flexible guidefeature 15 of the lead screw 5. The drive member 8 can especially be adrive sleeve of essentially cylindrical shape, the axis of the drivesleeve being arranged parallel to the axis 4 of the device. The leadscrew 5 may be disposed to enter the drive member 8.

A removable and attachable part 11 of the body 1 may be provided as acartridge holder. When this part 11 is removed from the rest of the body1, a cartridge 12 can be inserted. When the part 11 is attached to thebody 1, the lead screw 5 is brought into contact with a piston 13, whichis provided to expel a drug from the cartridge 12. A bearing 14 may bearranged between the lead screw 5 and the piston 13 in order to preventany damage that might be caused by a relative movement between the leadscrew 5 and the piston 13. The lead screw 5 functions as a piston rod toadvance the piston 13 in the distal direction.

During a delivery operation, the lead screw 5 is helically moved in thedistal direction with respect to the body 1. The lead screw 5 is guidedby the lead screw nut 7, which is engaged with the screw thread 6 of thelead screw 5. Stop features, described below, are provided in the screwthread 6 of the lead screw 5 to enable a set operation, by which a fixeddose that is to be dispensed can be preset. For this purpose, the drivemember 8 is drawn in the proximal direction relatively to the body 1 andto the lead screw 5. The drive member 8 is coupled with the lead screw5. In the embodiment shown in FIG. 1, the coupling is achieved with thescrew thread 18 of the drive member 8 and the flexible guide feature 15of the lead screw 5. During the set operation, the lead screw 5 must notbe moved. Therefore, the engagement between the drive member 8 and thelead screw 5 is temporarily released during the set operation. This maybe achieved by a deformation of the flexible guide feature 15 tooverride the screw thread 18 of the drive member 8. In spite of theengagement between the drive member 8 and the lead screw 5, the drivemember 8 can therefore be moved without being rotated, while the leadscrew 5 stays stationary with respect to the body. Overriding theengagement between the drive member 8 and the lead screw 5 isfacilitated by flexible guide features 15, which can be bent towards thecentral axis 4. A rotation of the drive member 8 with respect to thebody 1 may be prevented by guide features 10, which may be protrudingelements of the body 1 engaging an axial groove in the outer surface ofthe drive member 8, for instance.

After the drive member 8 has been moved a distance corresponding to thepitch of the screw thread 18 of the drive member 8, the flexible guidefeature 15 of the lead screw 5 reengages the screw thread 18 of thedrive member 8, and the user can advance the lead screw 5 by pushing thedrive member 8 back in the distal direction. This method of operation bydisengaging and reengaging the lead screw 5 with the drive member 8relies entirely on the lead screw 5 remaining substantially stationaryduring the setting operation. Should the lead screw rotate 5 or moveaxially during setting, then the drive member 8 would very likely notcorrectly reengage with the lead screw 5 and thus cause dose inaccuracy.Therefore, the lead screw nut 7 guiding the helical movement of the leadscrew 5 with respect to the body 1 is rotationally locked to the body 1at least during the dispense operation and, furthermore, the lead screw5 is provided with stop features interfering with the rotation of thelead screw 5 in such a manner that the rotation is inhibited in thepositions of the lead screw 5 which are obtained after the drug deliveryand before the setting of a new dose. The rotation of the lead screw 5is thus locked with respect to the lead screw nut 7, and the lead screwnut 7 is prevented from rotating relatively to the body 1. Therefore,when the drive member 8 is drawn in the proximal direction, the relativelinear motion between the drive member 8 and the lead screw 5 causes theengagement of the drive member and the stationary lead screw 5 to beoverridden and thus the engagement between the drive member 8 and thelead screw 5 to be released. The stop features are therefore preferablyarranged at least on the distal sidewall of the screw thread 6 of thelead screw 5, while the screw thread 6 may be smooth, forming a helix,on its proximal sidewall. When the drive member 8 is pushed in thedistal direction, a guide means of the lead screw nut 7 engaging thescrew thread 6 of the lead screw 5 stays in contact with the smoothproximal sidewall of the screw thread 6, thus enabling a smooth helicalmovement of the lead screw 5 sliding through the opening of the leadscrew nut 7. Therefore, the stop features do not interfere with therelative motion of the lead screw 5 with respect to the lead screw nut 7during the dispense operation.

The stop features may especially be provided by recesses of a helicalgroove forming the screw thread 6 of the lead screw 5. The recesses canhave contact faces arranged transverse to the axis 4 and interruptingthe smooth helix of the relevant sidewall of the groove forming thescrew thread 6. The contact faces may especially be flat portions,essentially perpendicular to the axis 4 or at least having zero helixangle, but may comprise a rake angle in the radial direction. A drivefeature of the lead screw nut 7 may be formed in such a manner that itenters the recesses and stops on the contact face. When the drivefeature of the lead screw nut 7 comes into contact with one of the flatportions, the generally perpendicular orientation of the flat portionwith respect to the axis 4 causes the guidance of the helical movementof the lead screw 5 with respect to the body 1 to be stopped. It may befavorable if the drive feature of the lead screw nut 7 that engages withthe screw thread 6 of the lead screw 5 and is stopped in the recesses ismade up of one or more individual drive features and is not formed by acompletely continuous helix. The stop features are arranged in such afashion that, after a dose of the drug has been fully delivered and thedevice is ready for the next dose to be set, one of the stop features isin a position ready to stop the rotation of the lead screw 5 when thedrive member 8 is pulled in the proximal direction. The axial loadexerted on the lead screw 5 is then compensated by the drive feature ofthe lead screw nut 7 engaging the relevant stop feature, particularlycontacting the essentially flat portion of the relevant recess. Thisacts to lock the rotation of the lead screw 5 rather than rotate it,because the lead screw nut 7 is rotationally locked to the body 1 atleast during the operations of setting and dispensing a dose.Essentially, the flat surfaces on the screw thread 6 are designed toprevent a back-driving of the lead screw 5 during a set operation. Themotion of the lead screw 5 may thereby be restricted to the distaldirection.

FIG. 2 shows an enlarged perspective view of an embodiment of the leadscrew 5. The lead screw 5 comprises a screw thread 6 and may comprise atleast one further screw thread 16. If a further screw thread 16 isprovided, the screw thread 6 and the further screw thread 16 have thesame pitch and are intertwined. This means that the lead screw 5 has twoco-axial helical features with separate entries at or near the distalend of the lead screw 5. The screw thread 18 of the drive member 8 mayalso have two separate co-axial helical features, which are intertwined.The shape of the flexible guide feature 15 at the proximal end of thelead screw 5 is adapted to the screw thread 18 of the drive member 8.The flexible guide feature 15 may especially comprise two co-axialhelical male thread features provided to engage helical groves, whichmay form the screw thread 18 of the drive member 8. If there are twoco-axial helical features of the screw thread 18, there may be twoseparate parts of the flexible guide feature 15, each of the partsengaging one of the helical features. The flexible guide feature 15 canbe deformed and thus disengaged from the screw thread 18 of the drivemember 8. This allows the coupling between the lead screw 5 and thedrive member 8 to be temporarily overridden when the drive member 8 ispulled in the proximal direction.

FIG. 3 shows a cross-section of the lead screw nut 7. The drive feature19 protruding from a surface 21 of the internal bore of the lead screwnut 7 may comprise a stop section 20, which is adapted to the form ofthe stop features of the lead screw 5. The drive feature 19 may compriseseparate portions, which may each engage one of the screw threads 6, 16of the lead screw 5. The drive feature 19 of the lead screw nut 7 may betapered towards the screw thread 6 of the lead screw 5, as shown in FIG.3. A tapered drive feature 19 may be especially advantageous inconjunction with a screw thread 6, 16 of the lead screw 5 that has anon-zero opening angle in the radial directions with respect to thecentral axis 4.

FIG. 4 shows an enlarged detailed view of the distal end of the leadscrew 5. In this embodiment the lead screw 5 comprises a screw thread 6and a further screw thread 16 with surfaces 23. The drive feature 19 ofthe lead screw nut 7 engages the screw threads 6, 16 of the lead screw 5between the surfaces 23, which form a non-zero angle 22 in the radialdirections 24. The set of screw threads 6, 16 at the distal end of thelead screw 5 have thus a buttressed form, i.e. the surfaces 23 providingthe contact faces of the screw threads are angled rather than flat. Thisfeature helps to ensure that the lead screw 5 remains central within thelead screw nut 7, and therefore central in the body 1, when a dose isdispensed. This reduces the risk of the lead screw 5 catching on the rimof the cartridge 12 and also facilitates the construction and assemblyof the device.

The drive feature 19 of the lead screw nut 7 may especially comprisethree separate portions, each having the shape of a thread feature. Theportions may be approximately angularly equi-spaced on the inner surfaceof the internal bore of the lead screw nut 7. When the dispensing loadof the lead screw 6 is reacted by the buttressed or tapered portions ofthe drive feature 19 of the lead screw nut 7, the geometry of thecontacting thread surfaces creates a component of force from each of thethree thread features towards the centre of the lead screw 5. Two ormore portions of the drive feature 19 of the lead screw nut 7 may engagethe same screw thread 6, 16 of the lead screw 5. Instead, each portionof the drive feature 19 may engage a different one of the screw threads6, 16 of the lead screw 5.

The buttressed thread form and the intertwined separate co-axial helicalstructures are two features of the screw thread 6 of the lead screw 5which help to improve the working of the mechanism, particularly tofacilitate the relative movement of the lead screw 5 and the lead screwnut 7. These improvements can be obtained by implementing these featuresindividually or in conjunction with one another

1. A drive mechanism for a drug delivery device, comprising: a leadscrew and a lead screw nut aligned with an axis defining an axialdirection and an opposite axial direction, a screw thread and at leastone further screw thread of the lead screw, the screw thread and thefurther screw thread having the same pitch and being intertwined, and adrive feature of the lead screw nut, the drive feature engaging thescrew thread and the further screw thread and allowing for a dispenseoperation a helical movement of the lead screw with respect to the leadscrew nut at least in the axial direction.
 2. The drive mechanismaccording to claim 1, further comprising: the axis further definingradial directions diverging from the axis, the screw thread and thefurther screw thread of the lead screw having surfaces, the drivefeature engaging the screw thread between the surfaces, and the surfacesof the screw thread forming a non-zero angle in the radial directions.3. The drive mechanism according to claim 1, further comprising: a drivemember rotationally locked with the lead screw nut, the lead screw beingcoupled with the drive member, the coupling generating a helicalmovement of the lead screw with respect to the drive member when thedrive member is moved in the axial direction with respect to the leadscrew, and the coupling being overridden to prevent a helical movementof the lead screw with respect to the drive member when the drive memberis moved in the opposite axial direction with respect to the lead screw.4. The drive mechanism according to claim 3, further comprising: aflexible guide feature of the lead screw, and a screw thread of thedrive member, the flexible guide feature of the lead screw and the screwthread of the drive member providing the coupling of the lead screw withthe drive member.
 5. The drive mechanism according to claim 4, whereinthe screw thread of the drive member has two separate co-axial helicalfeatures.
 6. The drive mechanism according to claim 3, furthercomprising: stop features of the lead screw, the stop featuresinhibiting the helical movement of the lead screw when the drive memberis moved in the opposite axial direction with respect to the lead screw.7. The drive mechanism according to claim 1, wherein the drive featureof the lead screw nut comprises at least two separate parts protrudingfrom an inner surface of the lead screw nut.
 8. The drive mechanismaccording to claim 1, wherein the drive feature of the lead screw nut istapered towards the screw thread of the lead screw.
 9. A drug deliverydevice, comprising: a drive mechanism according to claim 1, and a bodyhaving a distal end and a proximal end, which are spaced apart in thedirection of the axis.